Sunvozertinib for untreated advanced non-small cell lung cancer with uncommon EGFR mutations

a Study of Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

This will test whether the oral drug sunvozertinib can shrink tumors and be safe in adults with untreated advanced non‑small cell lung cancer who have uncommon EGFR mutations.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: sunvozertinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT07117890 on ClinicalTrials.gov

What this trial studies

This is a single-arm Phase 2 trial enrolling adults with untreated advanced non-squamous NSCLC who carry documented uncommon EGFR mutations (excluding exon 19 deletion, L858R, T790M, and exon 20 insertions). Eligible participants receive oral sunvozertinib at specified doses (200 mg or 300 mg) and are followed with regular imaging and clinical assessments. Tumor response will be measured by RECIST 1.1 and safety will be monitored through adverse event reporting and labs. The study is conducted at Fudan University Shanghai Cancer Center and focuses on anti-tumor activity and tolerability in this molecularly defined group.

Who should consider this trial

Good fit: Adults (≥18) with untreated advanced non-squamous NSCLC, a documented uncommon EGFR mutation (not exon 19del, L858R, T790M, or exon 20 insertion), measurable disease by RECIST 1.1, and a predicted life expectancy of at least 12 weeks are the intended participants.

Not a fit: Patients with common EGFR mutations (exon 19del, L858R, T790M, or exon 20 insertions), prior systemic anti-tumor therapy, squamous histology, recent other malignancies, active infections, or uncontrolled severe systemic disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, sunvozertinib could provide a targeted oral treatment that controls tumors for patients with uncommon EGFR mutations who currently have limited tailored options.

How similar studies have performed: Other EGFR tyrosine kinase inhibitors have shown activity for some uncommon EGFR mutations but responses are variable, so testing sunvozertinib in this setting is partially supported by prior work yet remains relatively novel for many mutation types.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years old
2. histologically or cytologically confirmed non-squamous NSCLC with documented EGFR uncommon mutations from a local laoratory. at least one EGFR uncommon mutation (excluding EGFR 19del/l858r/T790m/Ex 20ins ) or compund mutations with EGFR uncommon mutations.
3. predicted life expectancy ≥ 12 weeks.
4. patient must have measurable disease according to RECIST 1.1

Exclusion Criteria:

1. previos systemic anti-tumor therapy
2. a history of malignant tumors within 2years
3. any severa or poorly controlled systemic disease per investigator's judgement
4. active infections

Where this trial is running

Shanghai

• Fudan university shanghai cancer center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jialei Wang

Conditions Non Small Cell Lung Cancer; Sunvozertinib; EGFR; EGFR uncommon mutation